Clinical Research Associate II

hace 4 semanas

Palma, Baleares, España Pharmiweb A tiempo completo
About the Role

Parexel is a leading provider of biopharmaceutical services, dedicated to improving global health by transforming scientific discoveries into new treatments.

We are seeking a highly skilled Clinical Research Associate II to join our Clinical Operations Team in Spain, with the opportunity to work in an office-based setting in Madrid or decentralized in the regions of Madrid or Barcelona.

This role offers the chance to go beyond the typical clinical monitor role, with a focus on building and maintaining site relationships, ensuring their success, and addressing and resolving site issues and questions.

As the clinical sites' sole point of contact, you will manage site quality and delivery from site identification through to close-out, leveraging your expertise to promote rapport with the site and staff.

Key Responsibilities
  • Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
  • Build relationships with clinical sites, overseeing the integrity of the study and utilizing problem-solving skills to promote rapport with the site and staff.
  • Protect patients by reviewing the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are safeguarded and in accordance with protocol.
  • Drive productivity by developing patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while ensuring compliance with approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and applicable regulatory requirements.
  • Ensure quality by evaluating the quality and integrity of the reported data, site efficacy, and drug accountability, and executing monitoring activities to ensure the completeness and quality of Regulatory Documentation and site document verification.
Requirements
  • Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
  • Ability to perform all clinical monitoring activities independently.
  • Bachelor's or equivalent degree in biological science, pharmacy, or other health-related discipline.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Fluent knowledge of Spanish and English languages.
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
  • A client-focused approach to work and flexible attitude with respect to assignments/new learning.
  • The ability to manage multiple tasks, evaluate unpredictable scenarios, and achieve project timelines while applying understanding of study protocol(s).
  • An honest and ethical work approach to promote the development of life-changing treatments for patients.
  • Strong computer skills, including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

Parexel offers a world-class technology and training program, catering to individual experience, with less travel and a lower protocol load compared to industry peers. A bonus incentive program, opportunities to work within multiple therapeutic areas, and career advancement in clinical research are also available.

If you are ready to join Parexel's journey, please apply.

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